berad Blimey I really do need to get away from the...

berad

Blimey I really do need to get away from the keyboard...lol!

I am not sure you can rely on the Phase 2 results as definitive about what is therapeutically possible with CHF. This was discussed at the AGM where the CEO did indeed indicate that a greater response was detected by the more damaged patient.

As the aGVHD implementation shows, the Japanese are apparently more focussed on saving lives than slavish devotion to an old model; continuation of stage 3 in blind studies to demonstrate overwhelming efficacy is of questionable value in some ways as it almost certainly involves adverse events to patients using placebo. I am wanting clarification on the point about how much the Japanese will rely on FDA stage 2, and to what extent new tests will be done but contextually it seems from the statements made by Itescu, that they will.

I would suggest that the whole field of FDA testing needs more thorough review for stem cells and the Japanese are more progressive about it and saving patient lives. I am not saying all aspects of the rule book are being thrown out or should be thrown out but the fact of demonstrated patient safety is a new norm which I don't think the Americans have fully engaged with. Yet.

In answer to your question about exact numbers, I don't have an exact amount in terms of the market share, and revenue BUT patient who is a long term stay in hospital has huge costs. These will be weighed against the cost of administering a stem cell therapy. Of course the LT end points for efficacy are still ticking over. That's the nature of the beast.

I think we can agree that the CHF market is colossal.

Agree that the defib is an excellent low cost entry point. sorry if I can't speak lab talk but you get the principles involved. this is all IMO only. Of course.